Description
Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Brief Job Overview
This is a non-supervisory position in the Central Laboratory Operations (CLO) group of USP’s Global Laboratory and Technical Operations division. The incumbent will play a key role in support of many global and localized operational software needs, especially as related to the development, implementation, and maintenance of our Laboratory Information Management System (LIMS) and associated components. This role will support USP’s overall Computer System Validation (CSV) effort for laboratory software. The incumbent will work closely with other CLO and laboratory staff in the overall lifecycle management of analytical instrumentation and associated software. The incumbent is expected to utilize scientific, computing, engineering, and other skills to continuously monitor and improve laboratory systems and keep them operational.
How will YOU create impact here at USP?
In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
Responsibilities
By supporting our CSV effort, the Associate Laboratory Informatics Engineer will enable USP laboratories to adhere to ISO 9001 and 17025 standards. This includes the following responsibilities:
- Draft protocols to validate enhancements and new uses to the functionality of software systems, with the inclusion of new processes and/or procedures, in particular with respect to USP’s LIMS system, Empower custom fields, and validated spreadsheets that assist with automation for USP laboratories.
- Deploy LIMS forms to multiple laboratories across USP sites.
- Serve as a SME for various laboratory software within USP laboratories (for example: Waters Empower, Waters NuGenesis LMS/SDMS).
- Developing software related fixes in Python, SQL, Excel (VBA).
- Assist with implementation and monitoring of change control of laboratory software systems.
- Perform software validation and integrated testing to prove acceptable performance.
- Write, review, and execute validation protocols and reports.
- Assist in software project planning and development across various laboratories.
- Perform troubleshooting of laboratory software systems.
- Collaborate with QA, laboratories, and other CLO members to ensure software is maintained in compliance with ISO 9001 and 17025.
- Other duties as assigned.
Who is USP Looking For?
The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
- Bachelor’s degree in engineering, physical sciences or information technology with 6 years relevant laboratory and/or IT experience; OR MS degree in engineering with 2 years relevant laboratory and/or IT experience, physical sciences or information technology; OR 10 years of relevant laboratory and/or IT experience.
- 2-4 years’ experience in validation, qualification and/or testing.
- Familiarity with ISO 9001, ISO 17025, FDA and/or cGXP standards.
Additional Desired Preferences
- Six years of experience in the validation and/or qualification and/or testing of laboratory instrumentation software.
- Six years of experience working within an ISO 9001, ISO 17025, FDA and/or cGXP environment.
- Ability to handle multiple priorities in a fast-paced environment.
- Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm with customers across the organization.
- Able to work independently with limited supervision.
- Able to work flexible hours with advance notice.
- Strong analytical skills.
- Knowledge of programming languages (e.g., Python, SQL, VBA).
- Knowledge of database theory background and experience.
- Advanced excel programming knowledge.
Supervisory Responsibilities
None, this is an individual contributor role.
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
Compensation
Base Salary Range: USD $72,000.00 – $91,500.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Information Technology
Job Type Full-Time
